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Atrial Fibrillation (AF)SAFE-PFANCT07621432

Deep Sedation vs. General Anesthesia for Pulsed Field Ablation in Atrial Fibrillation

A study testing Standardized Deep Sedation Protocol and Standard General Anesthesia in people with Atrial Fibrillation (AF), run by Second Affiliated Hospital of Nanchang University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

1. Research Title: A Study on the Safety and Efficacy of Deep Sedation With Dexmedetomidine Combined With Remimazolam and Remifentanil Versus General Anaesthesia for Radiofrequency Ablation of Atrial Fibrillation 2. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
Standardized Deep Sedation Protocol and Standard General Anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteChina
Study dates
25 May 2026to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75 years, inclusive
  • Clinically diagnosed atrial fibrillation
  • Indicated for pulsed field ablation and scheduled for pulsed field ablation catheter procedure
  • Able and willing to provide written informed consent
  • Willing to comply with study procedures and follow-up requirements

Who cannot join

  • Left atrial diameter >55 mm
  • Presence of left atrial thrombus detected by transesophageal echocardiography
  • Contraindications to anticoagulation therapy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Qi Chen, MD, PhD, +86-13330087688, efycq@189.cn

Other trials in China

About this study

Official title: A Study on the Safety and Efficacy of Deep Sedation With Dexmedetomidine Combined With Remimazolam and Remifentanil Versus General Anaesthesia for Radiofrequency Ablation of Atrial Fibrillation

  1. Research Title: A Study on the Safety and Efficacy of Deep Sedation With Dexmedetomidine Combined With Remimazolam and Remifentanil Versus General Anaesthesia for Radiofrequency Ablation of Atrial Fibrillation
  2. Research Objective: The aim of this study is to compare the safety and efficacy of deep sedation using a combination of dexmedetomidine and remimazolam versus remifentanil, and general anaesthesia, in patients undergoing pulsed electric field ablation for atrial fibrillation. Through this study, we hope to optimise the management of the perioperative period for atrial fibrillation pulse field ablation and develop a carefully designed deep sedation protocol based on modern pharmacology. This protocol will maximise patient comfort, facilitate the surgeon's procedure, and enhance the efficiency of overall healthcare resource utilisation, whilst ensuring surgical success and patient safety. Consequently, it will provide crucial anaesthetic support for the standardisation and widespread adoption of atrial fibrillation pulse field ablation technology.
  3. Study Design: Interventional clinical study
  4. Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation at the Second Affiliated Hospital of Nanchang University between January 2026 and January 2027.
  5. Sample Size: N=80 patients, randomly assigned using a computer-generated random number table to the deep sedation group (n=40) or general anesthesia group (n=40) at a 1:1 ratio.
  6. Inclusion and Exclusion Criteria: Inclusion Criteria: ① Age 18-75 years (inclusive); ② Clinically diagnosed with atrial fibrillation, indicated for pulse field ablation, and scheduled for catheter ablation; ③ Voluntarily agrees to participate in the trial and has signed informed consent; ④ Willing to comply with the trial requirements and complete the required follow-up. Exclusion Criteria: ① Left atrial diameter > 55 mm; ② Transesophageal echocardiography indicates a thrombus in the left atrium; ③ Contraindications to anticoagulation
  7. Observational Indicators:(1) Baseline Data: Age, sex, BMI, type of atrial fibrillation, CHA2DS2-VASc score, hemoglobin, left atrial diameter, ejection fraction, and the prevalence of diabetes, hypertension, congestive heart failure, stroke/TIA, coronary heart disease and renal impairment.(2) Surgical Data: Duration of interventional procedures, X-ray exposure, operating theatre occupancy time, success rate of acute PVI, calibration deviation rate, incidence of hypoxemia and hypotension, Numerical Rating Scale (NRS) scores for pain, and postoperative complications.
  8. Statistical Analysis: Data analysis was performed using IBM SPSS Statistics 26.0 software; continuous variables following a normal distribution are expressed as mean ± standard deviation, and comparisons between two independent samples were performed using t-tests; categorical variables are presented as frequencies and percentages, and comparisons were performed using chi-square tests; a two-sided P-value of <0.05 was considered statistically significant.
Being tested
Standardized Deep Sedation Protocol, Standard General Anesthesia
Keywords
atrial fibrillation, pulse field ablation, deep sedation, general anesthesia, Catheter ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized Deep Sedation ProtocolProcedure or surgery

    A deep sedation protocol using dexmedetomidine, remifentanil and remazolam for atrial fibrillation pulse field ablation

  • Standard General AnesthesiaProcedure or surgery

    Atrial fibrillation pulse filed ablation using a standard endotracheal intubation general anaesthesia protocol

Study groups in NCT07621432
Study groupRoleWhat they receive
Deep Sedation GroupExperimentalPatients undergoing atrial fibrillation pulsed field ablation under a novel deep sedation protocol
Receives: Procedure: Standardized Deep Sedation Protocol
General Anesthesia GroupPlacebo comparatorPatients undergoing atrial fibrillation pulsed field ablation under general anesthesia
Receives: Procedure: Standard General Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operating Room Occupancy Time

    The duration from the patient's entry into the operating room to their departure from the room. This includes anesthetic induction, the surgical procedure, and emergence/extubation.

    Measured: From Operating Room entry to Operating Room exit

  2. Net Procedure Duration

    Defined as the time from the first skin puncture for vascular access to the removal of the last catheter.

    Measured: During the procedure

Secondary outcomes (7)

  1. Post-operative Recovery Time

    The time interval from the end of the procedure until the patient meets the criteria for transfer back to the general ward

    Measured: From procedure completion to transfer to the general ward, assessed up to 24 hours post-procedure

  2. Acute Pulmonary Vein Isolation (PVI) Success Rate

    The percentage of pulmonary veins successfully isolated using pulsed field ablation (PFA) as confirmed by the electrophysiological mapping system.

    Measured: At the end of the ablation procedure

  3. Incidence of Hypoxemia

    Percentage of patients experiencing oxygen saturation (SpO2) < 90% requiring intervention (e.g., increasing oxygen flow or airway maneuvers).

    Measured: Periprocedural period

  4. Incidence of Hypotension

    Percentage of patients experiencing at least one episode of hypotension during the procedure. Hypotension is defined as a Systolic Blood Pressure (SBP) < 90 mmHg or a decrease of more than 20% from the baseline value, requiring clinical intervention (such as fluid bolus or administration of vasopressors like phenylephrine or ephedrine).

    Measured: Periprocedural period

  5. Patient Pain Intensity (NRS Score)

    Patient-reported pain levels assessed using the Numerical Rating Scale (0-10, where 0 is no pain and 10 is the worst pain imaginable).

    Measured: 2 hours and 24 hours post-operation

  6. Total Fluoroscopy Dose (DAP)

    The cumulative radiation exposure to the patient, measured as Dose Area Product (DAP) in cGy·cm².

    Measured: At the end of the procedure

  7. Incidence of Perioperative Complications

    Occurrence of procedure-related adverse events, including cardiac tamponade, stroke/TIA, vascular access site complications (e.g., hematoma, pseudoaneurysm), phrenic nerve injury, and anesthesia-related complications.

    Measured: up to 30 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start25 May 2026 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07621432
Sponsor's protocol ID
IIT-2026-026
Acronym
SAFE-PFA
Status last verified
May 2026
First submitted
16 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rillig A, Hirokami J, Moser F, Bordignon S, Rottner L, Shota T, My I, Urbani A, Lemoine M, Kheir J, Schenker N, Urbanek L, Govorov K, Schaack D, Obergassel J, Riess J, Ismaili D, Kirchhof P, Ouyang F, Schmidt B, Reissmann B, Chun KJ, Metzner A. General anaesthesia and deep sedation for monopolar pulsed field ablation using a lattice-tip catheter combined with a novel three-dimensional mapping system. Europace. 2024 Nov 1;26(11):euae270. doi: 10.1093/europace/euae270.

    PubMed 39576055

  • Sochorova V, Kunstatova V, Osmancik P, Duska F, Herman D, Waldauf P, Poviser L, Karch J, Znojilova L, Filipcova V, Hozmanova J, Vesela J, Hozman M. COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial. Circulation. 2025 Jul 22;152(3):150-159. doi: 10.1161/CIRCULATIONAHA.125.074427. Epub 2025 Apr 27.

    PubMed 40287932

Questions about this trial

What is this clinical trial studying?

A study testing Standardized Deep Sedation Protocol and Standard General Anesthesia in people with Atrial Fibrillation (AF), run by Second Affiliated Hospital of Nanchang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operating Room Occupancy Time (time frame: From Operating Room entry to Operating Room exit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07621432, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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